September 12, 2022
Literature reviews are an essential part of the clinical evaluation process for medical devices. The clinical evaluation report assesses a medical device's benefit-risk profile to ensure its continued safety, efficiency, and compliance. Most regulatory [...]
September 17, 2020
Medical device regulations in China are often similar to the European Union (EU)’s MDR. With a vital prerequisite of Clinical Evaluation Reports (CERs), as required by China’s National Medical Products Administration NMPA (formerly CFDA). [...]
July 15, 2020
The MDSW is defined as a Medical Device regardless of its location of use. Software driving or influencing a medical device's use can qualify as a device. Software intentionally to process, analyze, create or [...]
June 30, 2020
Guide - MDCG endorsed documents and other guidance documents. The majority of documents on this site need approval by the Medical Device Coordination Group (MDCG) as per Article 105 of the MDDR and Article [...]
June 12, 2020
What will the new EU regulations mean for in vitro diagnostics? In 2022 the long-running IVDD will be replaced by another system called IVDR, thus inaugurating a new era for the regulations of InV. [...]
June 2, 2020
The EU IVDR Regulation - An Overview - Part I The PIP breast implant scandal brought to light weaknesses in the overall regulatory process to control IVDs. It may include - The certification [...]
May 22, 2020
The new EU MDR Regulations Everything you needed to know in 2020 The final period for compliance with EU medical device regulation shall be May 26, 2020. Formed today, introducing the new regulations means [...]
May 11, 2020
The EU MDR Delay – What It Means For Your Medical Devices With the global COVID-19 pandemic disrupting industries, medical device stakeholders have rapidly diverted efforts from the short-term urgency of ensuring regulatory compliance [...]
May 5, 2020
EU MDR Clinical Evaluation Requirement – Understanding the CER A critical component of the Technical File Submission for the CE Marking /conformity assessment process is that clinical evaluation reports are essential to selling or [...]
January 8, 2020
MDCG's Guidance document, released in July 2020, introduces and details the essential requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its [...]